AFFINITY BLOOD PUMP SYSTEM— 510(k) K964017

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K964017 for AFFINITY BLOOD PUMP SYSTEM, Substantially Equivalent on 1997-08-05. Applicant: Avecor Cardiovascular, Inc..

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1996-10-07
Decision date: 1997-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.